[Hiring] Director, Business Development – Clinical Trial Technology @Massive Bio

Role Description

You sell SentinelAgent™ to oncology sponsors, then make sure every site closure it supports is documented to the standard an FDA or EMA inspector expects. Both halves are yours.

You report to the CEO, with a dotted line to the Chief Medical AI Officer. About 80% of your week is business development and client delivery. The other 20% is product support: bringing what sponsors and sites tell you to the product team, and checking that what we ship matches how a study coordinator actually works a close-out.

This seat exists because sponsor pilots are under way and the next wave needs to be sold, papered and delivered by someone who has worked on the data side. You have entered case report form (CRF) data in a US electronic data capture (EDC) system as a coordinator, or source-verified it as a monitor, and ideally both. You have conducted close-out visits as a CRA or hosted them as the site coordinator. Then you moved into sponsor-facing business development. If none of that describes you, this is not the seat.

It is a player-coach seat with no team to start. You write the proposals, run the sponsor cadence and sit in the close-out reviews yourself. Twelve months out, the picture is a pipeline of signed pilots converting into multi-study agreements, zero inspection findings on any close-out we supported, and the budget to hire a clinical delivery lead. You hire them.

What you'll do

• Business development and client delivery (80%)
  • Run the pipeline with the CEO.
  • Target oncology sponsors with studies in post-treatment or long-term follow-up, run the "select a study" session with clinical development, clinical operations and procurement, and turn it into a costed pilot proposal within ten business days.
  • Convert pilots.
  • Own the sponsor relationship from kickoff through readout: the weekly cadence, the gating inputs (consent language, Schedule of Assessments, EDC access, site-entered comparison data) and the readout package. Turn the result into the next phase and a multi-study agreement.
  • Paper every engagement correctly.
  • Price off the approved rate card.
  • Sell the evidence.
  • Support compliant close-out on every engagement.
  • Own the Site Close-Out Compliance Checklist as a controlled document in our quality system, mapped to FDA and EMA requirements and reviewed quarterly with our QA/Regulatory lead and after every protocol amendment, inspection finding or regulatory change.
  • Build the commercial side of the partner layer: EDC vendors, ePRO/eCOA platforms, and CRO and SMO channels.
• Product support (20%)
  • A weekly hour with the Product Lead. Every sponsor and site ask is logged with persona, source and date. You bring the asks; Product writes the requirements.
  • Confirm that EDC pre-fill follows each sponsor's CRF completion guidelines and that the worklist matches how a coordinator actually works a close-out.
  • Serve as the site-workflow expert in user acceptance testing before each release. QA owns the validation record.

Qualifications

• 7+ years in US clinical research, with substantial hands-on time on the data side at a site, SMO or CRO.
• Close-out visits you conducted or hosted: essential-record reconciliation, investigational product accountability, SAE reconciliation queries, database-lock support, IRB/EC notifications, retention instructions.
• Sponsor-facing business development, alliance or account management at a CRO, SMO, eClinical vendor or site network, with at least one pilot you turned into a contract.
• Working knowledge of the FDA and EMA regulations.
• Healthcare contracting under fair-market-value and anti-kickback constraints.
• Evidence-based selling: a concordance table, a time-motion study and an ROI model carry your meetings.

Requirements

• Oncology long-term and survival follow-up operations; RECIST; Schedule of Assessments design.
• Ex-US site experience (UK, EU, Canada, Australia) and Japan exposure (PMDA, APPI).
• ePRO/eCOA operations.
• Experience as the first commercial hire on a product line.

Benefits

• Remote work flexibility.
• Opportunity to build and lead a team.
• Engagement with leading oncology sponsors globally.

Company Description

Massive Bio is an AI-powered precision medicine platform transforming how cancer patients discover and access clinical trials by eliminating barriers of geography, financial constraints, and information asymmetry.

Founded in 2015 and headquartered in the US, Massive Bio is scaling its impact globally by powering operations across multiple countries and bringing innovative cancer treatment options to a rapidly growing and diverse population of patients.

Through our proprietary AI platform, we connect individuals to clinical trials worldwide and partner with leading pharmaceutical companies, contract research organizations (CROs), and healthcare systems to accelerate drug development and expand equitable access to cutting-edge therapies.